JP4698128B2 - Catheter with puncture sensor - Google Patents

Catheter with puncture sensor Download PDF

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Publication number
JP4698128B2
JP4698128B2 JP2003090225A JP2003090225A JP4698128B2 JP 4698128 B2 JP4698128 B2 JP 4698128B2 JP 2003090225 A JP2003090225 A JP 2003090225A JP 2003090225 A JP2003090225 A JP 2003090225A JP 4698128 B2 JP4698128 B2 JP 4698128B2
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Japan
Prior art keywords
electrode
distal end
end portion
catheter
insertion member
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JP2003090225A
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Japanese (ja)
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JP2004290582A (en
JP2004290582A5 (en
Inventor
高史 上野
佳孝 大村
敬 山本
哲夫 田中
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テルモ株式会社
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Priority to JP2003090225A priority Critical patent/JP4698128B2/en
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Publication of JP2004290582A5 publication Critical patent/JP2004290582A5/ja
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • A61N1/057Anchoring means; Means for fixing the head inside the heart
    • A61N1/0573Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook
    • A61N1/0575Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook with drug delivery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00026Conductivity or impedance, e.g. of tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082Catheter tip comprising a tool
    • A61M25/0084Catheter tip comprising a tool being one or more injection needles
    • A61M2025/0089Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082Catheter tip comprising a tool
    • A61M25/0084Catheter tip comprising a tool being one or more injection needles

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a catheter for injecting a therapeutic composition into a diseased part in a living body, particularly a cardiac ischemic site or its peripheral part.
[0002]
[Prior art]
The number of patients with ischemic heart disease is increasing year by year due to an increase in risk factors such as westernization of eating habits and increased social stress. In particular, the increase in patients with severe heart failure is a major problem in developed countries. For example, as many as 15 million new patients occur annually in the world.
[0003]
As therapeutic methods for such ischemic heart disease, gene therapy and cell therapy are being studied. Conventional catheters applicable to these treatment methods have an injection needle for injecting a therapeutic composition at the tip (see, for example, Patent Documents 1 to 8).
[0004]
Patent Literature 1 and Patent Literature 2 disclose a catheter having a spiral injection needle. Patent Literature 3 and Patent Literature 4 disclose a catheter having a contact-type sensor including a pressure sensor at a distal end portion.
[0005]
Patent Documents 5 and 6 disclose a catheter having a mechanism in which the inside of the catheter is subjected to negative pressure and the tip is fixed to the tissue by adsorption. Patent Document 7 discloses a puncture device that mechanically grasps a tissue and punctures the distal end portion fixed to the tissue.
[0006]
Patent document 8 is disclosing the catheter which has the injection needle which can be accommodated in a front-end | tip part, and the fixing device opened radially outward from a front-end | tip part. Note that Patent Literature 8 discloses both a fixing device having a sharp tip and a fixing device having a sharp tip.
[0007]
[Patent Document 1]
Japanese National Patent Publication No. 8-508917
[Patent Document 2]
US Pat. No. 5,797,870
[Patent Document 3]
US Pat. No. 6,254,573
[Patent Document 4]
JP 2001-87392 A
[Patent Document 5]
US Pat. No. 5,597,2013
[Patent Document 6]
Special table 2001-516625 gazette
[Patent Document 7]
US Pat. No. 5,931,810
[Patent Document 8]
US Pat. No. 6,102,887
[0008]
[Problems to be solved by the invention]
However, the spiral needles according to Patent Document 1 and Patent Document 2 are prevented from falling out of the tissue when the therapeutic composition is injected, and can be reliably injected. Will not come off. Therefore, for example, when the distal end portion of the catheter moves erroneously in a state where the spiral needle is stuck in the fragile infarcted myocardial tissue, the spiral needle may tear the myocardial tissue.
[0009]
The contact-type sensor according to Patent Literature 3 and Patent Literature 4 is disposed on the end face of the distal end portion of the catheter, and needs to be brought into reliable contact with the myocardial tissue. However, since the irregularity inside the heart is severe, the contact sensor is likely to generate errors and has a problem in accuracy.
[0010]
The catheters according to Patent Document 5 and Patent Document 6 are intended for use in flat areas not filled with body fluid such as blood. Therefore, when applied to a tissue surface that is not necessarily flat and filled with body fluid, it is difficult to bring the catheter tip into close contact with the tissue surface, and there is a risk that body fluid may be aspirated.
[0011]
The puncture device according to Patent Document 7 has a relatively strong pericardium as a target to be gripped. For example, when applied to a fragile tissue such as an infarcted myocardial tissue, the tissue may be torn off.
[0012]
The fixing device with a sharp tip according to Patent Document 8 can fix a catheter to a tissue at the time of puncturing a tissue and injecting a therapeutic composition, but radially after being stabbed into a target tissue. Can be spread. Therefore, the invasion to the periphery of the target tissue is very large. In addition, the fixing device with a sharp tip according to Patent Document 8 pushes and spreads the meat column in the heart and fixes the catheter to the tissue, so that the operation of the catheter is very difficult, and any part in the heart The catheter cannot be fixed to the
[0013]
The present invention has been made to solve such a conventional problem, and is a catheter and catheter system capable of reliably achieving puncture by a needle and injection of a therapeutic composition to a target tissue with minimal invasiveness. Is to provide.
[0015]
[Means for Solving the Problems]
To achieve the above object, the present invention is configured as follows.
[0016]
  (1) A catheter that is percutaneously inserted into a body lumen,
  A sheath having a lumen extending the interior;
  An insertion member that is slidably disposed on the lumen of the sheath portion and has a distal end portion that can protrude from the distal end portion of the sheath portion;
  An injection needle disposed at the distal end of the insertion member for injecting a therapeutic composition into a target tissue in a living body;
  An electrode disposed at the distal end of the catheter, for measuring the action potential of the heart,
  The electrode is at the tip of the insertion member.FixedHaving an electrode,
  At the tip of the insertion memberFixedThe electrode to be operated is an outer peripheral surface of the distal end portion of the insertion memberLocated at a distance from the bevel of the injection needle at the tip of the insertion member,It is electrically insulated with respect to the inner peripheral surface of the tip of the insertion member
  A catheter characterized by that.
[0017]
(2) The catheter according to (1), wherein the target tissue is a heart tissue.
[0018]
  (3) The said therapeutic composition contains a nucleic acid, protein, or a cell, The said (1) characterized by the above-mentioned.Or (2)The catheter according to 1.
[0019]
  (4) The tip of the sheath has a through hole communicating with the lumen (1)Any one of-(3)The catheter according to 1.
[0020]
(5) The catheter according to (4), wherein the through hole is separated from an end surface of a distal end portion of the sheath portion by 1 mm or more with respect to a longitudinal direction of the sheath portion.
[0021]
(6) The electrode is connected to a conductor covered with an electrical insulator, and the conductor extends to a proximal end portion of the catheter. Catheter.
[0023]
  (7)Placed at the tip of the catheterThe electrode isMultipleArranged at the tip of the sheathContains electrodes(1) characterized in thatAny one of-(6)The catheter according to 1.
[0025]
  (8The injection needle is made of a conductive material,
  The electrode is formed on a bevel of the injection needle by covering an inner peripheral surface and an outer peripheral surface of the injection needle with an electrical insulator (7) Catheter.
[0027]
  (9) Arranged at the tip of the insertion memberSaidThe electrode is plural, and is spaced apart with respect to the longitudinal direction of the insertion member.1)Any one of to (8)The catheter according to 1.
[0028]
  (10) Arranged at the tip of the insertion memberSaidThe electrodeIt is located only on the outer peripheral surface of the distal end portion of the insertion member,The longitudinal direction of the insertion member is 1 mm or more away from the tip of the injection needle.1)Any one of to (9)The catheter according to 1.
[0029]
  (11The electrode disposed at the distal end of the sheath is electrically insulated from the injection needle.7) Catheter.
[0030]
  (12) A sheath portion having a lumen extending inside, an insertion member having a distal end portion that is slidably disposed on the lumen of the sheath portion and can protrude from the distal end portion of the sheath portion, and the insertion member A catheter that is disposed at the distal end and has an injection needle for injecting the therapeutic composition into a target tissue in the living body, and is percutaneously inserted into the living body lumen;
  A first electrode disposed at the distal end of the catheter for measuring a cardiac action potential;
  A second electrode for measuring the cardiac action potential;
  A conductor extending from the first electrode and a conductor extending from the second electrode are connected, and based on a heart action potential measured by the first electrode and the second electrode, A puncture detection device for detecting puncture,
  The first electrode is an outer peripheral surface of a distal end portion of the insertion memberAnd is spaced from the bevel of the injection needle at the tip of the insertion member,Electrically insulated with respect to the inner peripheral surface of the tip of the insertion member;
  The second electrode is disposed on the outer peripheral surface of the distal end portion of the insertion member or the distal end portion of the sheath portion, and is located closer to the proximal end of the catheter than the first electrode.
  A catheter system characterized by the above.
[0032]
  (13) A sheath portion having a lumen extending inside, an insertion member having a distal end portion that is slidably disposed on the lumen of the sheath portion and can protrude from the distal end portion of the sheath portion, and the insertion member A catheter that is disposed at the distal end and has an injection needle for injecting the therapeutic composition into a target tissue in the living body, and is percutaneously inserted into the living body lumen;
  A first electrode disposed at the distal end of the catheter for measuring a cardiac action potential;
  A second electrode for measuring the cardiac action potential;
  A conductor extending from the first electrode and a conductor extending from the second electrode are connected, and based on the action potential of the heart measured by the first electrode and the second electrode, by the injection needle A puncture detection device for detecting puncture,
  The first electrode is an outer peripheral surface of a distal end portion of the insertion memberAnd is spaced from the bevel of the injection needle at the tip of the insertion member,Electrically insulated with respect to the inner peripheral surface of the tip of the insertion member;
  The catheter system, wherein the second electrode is formed as a separate body independent of the catheter.
[0036]
DETAILED DESCRIPTION OF THE INVENTION
Embodiments according to the present invention will be described below in detail with reference to the drawings.
[0037]
As shown in FIG. 1, the catheter 20 according to the first embodiment includes an operation part 30, a sheath part 55, an injection needle 63 disposed at the distal end part 62 of the insertion member 60, and an electrode 70. It is used by being percutaneously inserted into the body lumen. In addition, the electrode 70 is arrange | positioned at the front-end | tip part 62 of the penetration member 60, is used in order to measure the action potential (electrocardiogram) of the heart, and functions as a puncture sensor.
[0038]
The operation unit 30 is located at the proximal end portion 21 of the catheter 20, and the distal end portion 62 and the injection needle 63 of the insertion member 60 are located at the distal end portion 22 of the catheter 20.
[0039]
The sheath portion 55 has a lumen extending inside, and the insertion member 60 extends slidably. Although the shape of the sheath part 55 is not specifically limited, It is preferable that it is cylindrical. Although the outer diameter of the sheath part 55 is not specifically limited, It is preferable that it is 10 French (3.3 mm) or less.
[0040]
The material of the sheath portion 55 is not particularly limited, but polyolefin, olefin elastomer, polyester, soft polyvinyl chloride, polyurethane, urethane elastomer, polyamide, amide elastomer, polytetrafluoroethylene, fluororesin elastomer, polyimide, ethylene- Polymer materials such as vinyl acetate copolymer and silicone rubber can be used.
[0041]
The polyolefin is, for example, polypropylene or polyethylene. The olefin elastomer is, for example, a polyethylene elastomer or a polypropylene elastomer. The amide elastomer is, for example, a polyamide elastomer.
[0042]
When the sheath portion 55 is formed from a synthetic resin, the rigidity can be improved by using, for example, a superelastic alloy pipe, an embedded coil or an embedded mesh made of metal.
[0043]
The distal end portion 57 of the sheath portion 55 preferably has a function as an X-ray contrast marker, and can be formed using, for example, a resin containing an X-ray contrast material. The X-ray contrast material is, for example, a powder of tantalum, tungsten carbide, bismuth oxide, barium sulfate, platinum or an alloy thereof, a cobalt alloy, or the like.
[0044]
The shape of the insertion member 60 is not particularly limited, but is preferably cylindrical. The outer diameter of the insertion member is not particularly limited as long as it can slide in the lumen of the sheath portion 55, but is preferably 0.3 to 1.0 mm. The inner diameter of the insertion member is preferably 0.15 to 0.8 mm.
[0045]
The material of the insertion member 60 is not particularly limited. For example, a metal such as stainless steel, Ni—Ti alloy, Cu—Zn alloy, cobalt alloy, tantalum, polyamide, polyimide, ultrahigh molecular weight polyethylene, polypropylene, fluororesin, or What combined these suitably is applicable.
[0046]
The injection needle 63 is used to inject the therapeutic composition into the target tissue. The target tissue is an affected part in a living body, for example, a heart tissue such as a cardiac ischemic site or its peripheral part. The injection needle 63 is formed by, for example, forming a bevel (blade surface) by applying a needle process to the distal end portion 62 of the insertion member 60, or attaching a separate injection needle to the distal end portion 62 of the insertion member 60. It is possible to configure.
[0047]
Next, the proximal end portion 21 and the distal end portion 22 of the catheter 20 will be described in detail with reference to FIGS.
[0048]
The operation unit 30 located at the proximal end 21 of the catheter 20 includes a housing 31 in which a slit 33 is formed as shown in FIG. 2, and an output terminal 50 for connection to an external biological amplifier (puncture detection device). And a hub 45.
[0049]
The output terminal 50 is connected to an electrode 70 disposed at the distal end portion 22 of the catheter 20 via a wire 80 extending along the insertion member 60. The hub 45 is a connector for injecting a therapeutic composition, and, for example, a syringe containing the therapeutic composition is connected thereto.
[0050]
A base end portion 56 of the sheath portion 55 is fixed to the housing 31, and a base end portion 61 of the insertion member 60 is introduced into the housing 31 and connected to the hub 45. On the inner surface of the housing 31, a drive unit 32 made of an elastic material is slidably disposed.
[0051]
The drive unit 32 has a central part to which the penetrating insertion member 60 is bonded and fixed, and an outer peripheral part to which the needle control unit 40 is fixed. The needle control unit 40 is slidably inserted into a slit 33 formed in the housing 31.
[0052]
Therefore, the insertion member 60 is driven by operating the needle control unit 40 and moving the drive unit 32. As a result, the injection needle 63 disposed at the distal end portion 62 of the insertion member 60 protrudes from the distal end portion 57 of the sheath portion 55 (see FIG. 3) or retreats to the distal end portion 57 of the sheath portion 55 (see FIG. 4). .
[0053]
Since the drive unit 32 is formed of an elastic material and is disposed in close contact with the inner surface of the housing 31, it can be stopped at any position of the slit 33. A stopper 35 is disposed on the inner surface of the housing 31 for reliably controlling the moving distance of the drive unit 32.
[0054]
An O-ring 34 is disposed in the gap between the outer peripheral surface of the insertion member 60 and the inner peripheral surface of the base end portion 56 of the sheath portion 55, and seals the inside of the operation portion 30. For example, blood Prevent inflow.
[0055]
As shown in FIG. 3, the distal end portion 57 of the sheath portion 55 located at the distal end portion 22 of the catheter 20 has a through hole 58 that communicates with the lumen of the sheath portion 55. The through-hole 58 improves the blood flow inside and outside the sheath portion 55 and ensures the entry of blood into the distal end portion 22 of the catheter 20. In addition, it is preferable that the through-hole 58 is 1 mm or more away from the end surface of the front-end | tip part 57 of the sheath part 55 regarding the longitudinal direction of the sheath part 55. FIG.
[0056]
The electrode 70 for measuring the action potential of the heart has a ring shape and is caulked to the distal end portion 62 of the insertion member 60 whose outer peripheral surface excluding the bevel 63A of the injection needle 63 is covered with the electrical insulator 64. Fixed by. In FIG. 2, the electrical insulator 64 is not shown for the sake of simplicity.
[0057]
For example, there is a large difference in the action potential of the heart between when the electrode 70 is in blood and when it contacts the heart tissue. On the other hand, there is no significant difference in the action potential of the heart between the case where the electrode 70 is in contact with the heart tissue and the case where the electrode 70 is located inside the heart tissue.
[0058]
Therefore, it is preferable that the electrode 70 is arranged 1 mm or more and 3 mm or less away from the bevel 63A of the injection needle 63 with respect to the longitudinal direction of the insertion member 60. This is because, in this arrangement position, when a change in the action potential of the heart is measured, the injection needle 63 is surely present in the heart tissue.
[0059]
The shape of the electrode 70 is not particularly limited, and for example, it can be partially arranged in the circumferential direction. The fixing of the electrode 70 is not particularly limited, and for example, adhesion can be applied. The electrical insulator 64 is electrically insulative such as polyimide varnish or polyurethane resin.
[0060]
The electrode 70 is connected to a wire 80 extending from the output terminal 50 disposed in the operation unit 30. The wire 80 includes a conductive wire 81 having a terminal connected to the electrode 70 and an electrical insulator 82 covering the conductive wire 81. The conducting wire 81 is fixed to the electrical insulator 64 covering the outer periphery of the insertion member 60 by, for example, adhesion.
[0061]
That is, the electrode 70 is connected to a conducting wire 81 covered with an electrical insulator 82, and the conducting wire 81 extends to the proximal end portion 21 of the catheter 20. The material of the electrode 70 and the conductive wire 81 is not particularly limited, but platinum, platinum iridium, tungsten, silver and the like are preferable.
[0062]
When the insertion member 60 and the injection needle 63 are separate, the outer peripheral surface of the insertion member 60 is covered with the electrical insulator 64, and the electrode 70 and the wire 80 are disposed, and then the needle is attached. In this case, since it is not necessary to avoid the bevel 63A of the injection needle 63, the coating operation of the electrical insulator 64 is simplified. In addition, when the insertion member 60 is formed of an electrical insulator such as plastic, it is not necessary to cover the electrical insulator 64.
[0063]
Next, the catheter system 10 to which the catheter 20 is applied will be described with reference to FIG.
[0064]
The catheter system 10 includes a catheter 20, a second electrode 97 for measuring an electrocardiogram, and a biological amplifier 90 for detecting a waveform change in the cardiac action potential measured by the first electrode 70. The second electrode 97 is formed as a separate body independent of the catheter 20.
[0065]
The biological amplifier 90 has input terminals 91 and 95. For example, the input terminal 91 is for a positive electrode and the input terminal 95 is for a negative electrode. The input terminal 91 is connected to the output terminal 50 of the catheter 20 by a cord 92, and the first electrode 70 is disposed at the distal end portion 62 of the insertion member 60 via a wire 80 extending inside the sheath portion 55. Connected with. The input terminal 95 is connected to the second electrode 97 by a cord 96. That is, the biological amplifier 90 is connected to the first electrode 70 and the second electrode 97. The second electrode 97 is fixed at an appropriate position on the patient's body surface.
[0066]
Therefore, when the injection needle 63 punctures the myocardial tissue and the electrode 70 is in contact with or located inside the myocardial tissue, a large change occurs in the waveform of the action potential of the heart. Therefore, the biological amplifier 90 can determine that the waveform of the cardiac action potential has changed due to the puncture by the injection needle, for example, when the waveform pattern of the heart action potential has changed more than the level assumed in advance. It is possible to confirm puncture with an injection needle. The waveform pattern of the cardiac action potential differs depending on the puncture site.
[0067]
Next, the usage method of the catheter system 10 is demonstrated regarding the case where a heart tissue is made into the target site | part.
[0068]
First, the operator inserts the catheter 20 into the living body under fluoroscopy using, for example, a guiding catheter, and guides the distal end portion 22 of the catheter 20 into the ventricle located in the vicinity of the target tissue. .
[0069]
Blood flows into the distal end portion 57 of the sheath portion 55 due to blood pressure, and the action potential of the heart is measured by the electrode 70 located in the vicinity of the injection needle 63. At this time, the presence of the through-hole 58 formed in the distal end portion 57 of the sheath portion 55 ensures a good flow of blood inside and outside the sheath portion 55, so that the inflow of blood is ensured. Therefore, the action potential of the heart when the electrode 70 is present in the blood can be measured more accurately.
[0070]
Thereafter, the surgeon operates the needle control unit 40 while pressing the distal end portion 57 of the sheath portion 55 against the heart wall while measuring the action potential of the heart with the electrode 70. As a result, the insertion member 60 moves in the distal direction with respect to the sheath portion 55, the injection needle 63 protrudes from the distal end portion 57 of the sheath portion 55, and the myocardial tissue is punctured.
[0071]
When the injection needle 63 punctures the myocardial tissue, when the electrode 70 moves inside the myocardial tissue, a large change occurs in the waveform pattern of the action potential of the heart. Therefore, puncture by the injection needle 63 can be detected.
[0072]
Then, for example, using a syringe connected to the hub 45, the therapeutic composition is injected into the myocardial tissue via the injection needle 63. At this time, it is confirmed that no significant change occurs in the waveform pattern of the action potential of the heart. Thereby, it can be detected that the injection needle 63 is not detached from the target tissue due to the reaction of the injection operation of the therapeutic composition.
[0073]
After completion of the injection, the needle operating unit 40 is operated to retract the injection needle 63 into the distal end portion 57 of the sheath portion 55 and move the distal end portion 22 of the catheter 20 to the next target site. repeat.
[0074]
As described above, in the first embodiment of the present invention, based on the action potential of the heart measured by the electrode 70, the injection needle 63 is reliably punctured into the target tissue, and the therapeutic composition is applied to the injection needle 63. It is possible to reliably inject into the target tissue via. In addition, since a special device for fixing the catheter to the tissue is not required, it is minimally invasive.
[0075]
Next, a modified example of the catheter 20 according to Embodiment 1 will be described.
[0076]
The electrode for measuring the action potential of the heart is not limited to being disposed at the distal end portion 62 of the insertion member 60, and is disposed at the distal end portion 57 of the sheath portion 55 as shown in FIGS. It is also possible.
[0077]
The electrode 75 has a ring shape and is fixed to the end surface of the distal end portion 57 of the sheath portion 55 by caulking, for example. The electrode 75 is connected to a wire 85 extending from the output terminal 50 disposed in the operation unit 30.
[0078]
The wire 85 includes a conductive wire 86 having a terminal connected to the electrode 75 and an electrical insulator 87 covering the conductive wire 86. The conducting wire 86 is fixed to the outer periphery of the sheath portion 55 by, for example, adhesion. However, when the outer periphery of the sheath portion 55 is conductive, for example, the conductive wire 86 is fixed after covering the electrical insulator.
[0079]
The wire 85 is operated at the proximal end portion 56 of the sheath portion 55 via, for example, a gap between the outer periphery of the proximal end portion 61 of the insertion member 60 and the inner peripheral surface of the proximal end portion 56 of the sheath portion 55. It is introduced into the housing 31 of the part 30 and penetrates the drive part 32.
[0080]
Next, the usage method of the modification of the catheter 20 is demonstrated.
[0081]
Since the electrode 75 is disposed on the end face of the distal end portion 57 of the sheath portion 55, a large change occurs in the waveform pattern of the cardiac action potential before and after the distal end portion 57 of the sheath portion 55 contacts the myocardial tissue.
[0082]
For example, the catheter is inserted into the living body, advanced to the vicinity of the target tissue, and the distal end portion 57 of the sheath portion 55 is moved while measuring the action potential of the heart. Then, since a significant difference occurs in the waveform of the action potential of the heart, contact between the distal end portion 57 of the sheath portion 55 and the target tissue is recognized. Therefore, the needle operation portion 40 is operated, and the injection needle 63 is moved to the sheath portion 55. Project from the tip portion 57.
[0083]
At this time, when a large change occurs in the waveform pattern of the action potential of the heart, it is determined that the distal end portion 57 of the sheath portion 55 has moved away from the target tissue due to the reaction of the protruding operation of the injection needle 63. Therefore, it is possible to detect that the injection needle 63 has punctured the target tissue reliably by confirming that no significant change occurs in the waveform pattern of the action potential of the heart during the protruding operation of the injection needle 63. it can.
[0084]
Further, it is confirmed that even when the therapeutic composition is injected into the target tissue via the injection needle 63, no significant change occurs in the waveform pattern of the cardiac action potential. Accordingly, it can be detected that the distal end portion 57 of the sheath portion 55 is not separated from the target tissue by the reaction of the injection operation of the therapeutic composition, that is, that the injection needle 63 is not detached from the target tissue. it can.
[0085]
As described above, also in the modified example, it is possible to reliably puncture the target tissue with the injection needle 63 and reliably inject the therapeutic composition into the target tissue via the injection needle 63.
[0086]
Next, the catheter 120 according to Embodiment 2 will be described with reference to FIGS. The second embodiment is generally different from the first embodiment in that the distal end portion 162 of the insertion member 160 has a plurality of electrodes 170 and 175 that function as puncture sensors, and an electrode independent from the catheter is unnecessary.
[0087]
More specifically, the operation unit 130 located at the proximal end portion 121 of the catheter 120 has a plurality of output terminals 150 and 151. The output terminal 150 is connected to an electrode 170 disposed at the distal end portion 122 of the catheter 120 via a wire 180 extending along the insertion member 160. That is, the electrode 170 is connected to the terminal of the conducting wire 181 covered with the electrical insulator 182.
[0088]
The output terminal 151 is connected to an electrode 175 disposed at the distal end portion 122 of the catheter 120 via a wire 185 extending along the insertion member 160. That is, the electrode 175 is connected to the terminal of the conducting wire 186 covered with the electrical insulator 187. The electrode 170 and the electrode 175 are spaced apart with respect to the longitudinal direction of the insertion member 160.
[0089]
As shown in FIG. 12, the catheter system 110 to which the catheter 120 is applied has a biological amplifier 190 for detecting a waveform pattern of the cardiac action potential measured by the electrodes 170 and 175.
[0090]
The biological amplifier 190 has, for example, a positive input terminal 191 and a negative input terminal 193. The input terminal 191 is connected to the output terminal 150 of the catheter 120 by a cord 192, and is connected to the electrode 170 disposed at the distal end portion 162 of the insertion member 160 via a wire 180 extending inside the sheath portion 155. .
[0091]
The input terminal 193 is connected to the output terminal 151 of the catheter 120 by a cord 194, and is connected to an electrode 175 disposed at the distal end portion 162 of the insertion member 160 via a wire 185 extending inside the sheath portion 155. .
[0092]
Next, a method for using the catheter 120 will be described.
[0093]
The catheter 120 is inserted into the living body, the distal end 157 of the sheath 155 is pressed against the heart wall, and the needle controller 140 is operated. As a result, the insertion member 160 moves in the distal direction relative to the sheath 155, the injection needle 163 protrudes from the distal end 157 of the sheath 155, and punctures the myocardial tissue. When the injection needle 163 punctures the myocardial tissue and the electrode 170 moves into the myocardial tissue, a large change occurs in the waveform pattern of the action potential of the heart. Therefore, puncture by the injection needle 163 can be detected.
[0094]
As described above, also in the second embodiment, it is possible to reliably puncture the target tissue with the injection needle 163 and reliably inject the therapeutic composition into the target tissue via the injection needle 163.
[0095]
Next, a modification of the catheter according to Embodiment 2 will be described with reference to FIG.
[0096]
When arranging a some electrode in the front-end | tip part of a catheter, it is not limited to arrange | positioning in the front-end | tip part 162 of the penetration member 160, It is also possible to arrange | position to the front-end | tip part 157 of the sheath part 155.
[0097]
For example, the electrode 270 has a ring shape and is fixed to the end surface of the distal end portion 157 of the sheath portion 155 by caulking, for example. The electrode 270 is connected to a conductive wire 281 connected to a wire 180 extending from the output terminal 150 arranged in the operation unit 130. The conducting wire 281 is covered with an electrical insulator 282.
[0098]
The electrode 275 has a ring shape, is spaced from the electrode 270, and is fixed by caulking, for example. The electrode 275 is connected to a conducting wire 286 that is coupled to a wire 185 extending from the output terminal 151 disposed in the operation unit 130. The conductor 286 is covered with an electrical insulator 287.
[0099]
In such a configuration, as in the modification of the catheter 20 according to the first embodiment, a large change occurs in the waveform pattern of the action potential of the heart before and after the distal end 157 of the sheath 155 contacts the myocardial tissue. . Therefore, it is possible to reliably puncture the target tissue with the injection needle 163 and reliably inject the therapeutic composition into the target tissue via the injection needle 163.
[0100]
Next, a different configuration of the catheter system to which the catheter 120 is applied will be described with reference to FIG. The catheter system 210 includes a plurality of biological amplifiers 190 and 290 for detecting a waveform pattern of the cardiac action potential measured by the electrodes 170 and 175.
[0101]
The biological amplifier 190 has, for example, a positive input terminal 191 and a negative input terminal 195. The input terminal 191 is connected to the output terminal 150 of the catheter 120 by a cord 192, and is connected to the electrode 170 disposed at the distal end portion 162 of the insertion member 160 via a wire 180 extending inside the sheath portion 155. . The input terminal 195 is connected by a cord 196 to the second electrode 197 that is separate from the catheter.
[0102]
The biological amplifier 290 has, for example, a positive input terminal 291 and a negative input terminal 295. The input terminal 291 is connected to the output terminal 151 of the catheter 120 by a cord 292, and is connected to an electrode 175 disposed at the distal end portion 162 of the insertion member 160 via a wire 185 extending inside the sheath portion 155. . The input terminal 295 is connected to the second electrode 297 separate from the catheter by a cord 296.
[0103]
The electrode 170 and the electrode 175 are spaced apart with respect to the longitudinal direction of the insertion member 160. Therefore, the waveform pattern of the cardiac action potential measured by the electrode 170 and the electrode 175 sequentially changes as the depth of the injection needle 164 into the tissue increases. That is, the depth of the injection needle 164 can be detected.
[0104]
Next, a method for using the catheter 120 in the catheter system 210 will be described.
[0105]
The catheter 120 is inserted into the living body, the distal end 157 of the sheath 155 is pressed against the heart wall, and the needle controller 140 is operated. As a result, the insertion member 160 moves in the distal direction relative to the sheath 155, the injection needle 163 protrudes from the distal end 157 of the sheath 155, and punctures the myocardial tissue. When the injection needle 163 punctures the myocardial tissue and the electrode 170 moves into the myocardial tissue, a large change occurs in the waveform pattern of the cardiac action potential confirmed by the amplifier 190. Therefore, puncture by the injection needle 163 can be detected.
[0106]
At this time, if no significant change occurs in the waveform pattern of the cardiac action potential measured by the electrode 175 and confirmed by the amplifier 290, the depth of the injection needle 163 is intermediate between the positions of the electrode 170 and the electrode 175. Is determined. Further, when the puncture of the injection needle 163 is further advanced and the electrode 175 moves into the heart tissue, a large change occurs in the waveform pattern confirmed by the amplifier 290. Therefore, when the waveform pattern of the heart action potential measured by the electrode 175 and confirmed by the amplifier 290 is greatly changed, it is determined that the depth of the injection needle 163 exceeds the position of the electrode 175. The
[0107]
That is, it is possible to detect the depth of the injection needle 163 with high accuracy by appropriately changing the arrangement position and number of electrodes. Therefore, it is possible to prevent the injection needle 163 from projecting more than expected, for example, preventing the injection needle 163 from penetrating through the heart wall and puncturing the injection needle 163 to a depth not intended for the affected part.
[0108]
As described above, since the catheter 120 according to Embodiment 2 can detect the depth of the injection needle 163, the puncture of the injection needle 163 is more reliable. In addition, it is particularly suitable for treatment that requires effective insertion of the injection needle 163 at the target depth of the affected area.
[0109]
Next, a catheter according to Embodiment 3 will be described with reference to FIG. The third embodiment is generally different from the second embodiment in that it includes an electrode 370 disposed at the distal end portion 362 of the insertion member and an electrode 375 disposed at the distal end portion 357 of the sheath portion 355.
[0110]
More specifically, the electrode 370 has a ring shape, and the distal end portion 362 of the insertion member is covered with an electrical insulator 364 except for the bevel 363A of the injection needle 363. It is fixed to the tip 362 of the member by caulking.
[0111]
The electrode 370 is connected to a wire 380 extending from an output terminal arranged in the operation unit. The wire 380 includes a conductive wire 381 having a terminal connected to the electrode 370 and an electrical insulator 382 covering the conductive wire 381. The conducting wire 381 is fixed to the electrical insulator 364 covering the outer periphery of the insertion member 360 by, for example, adhesion.
[0112]
The electrode 375 disposed on the end surface of the distal end portion 357 of the sheath portion has a ring shape and is fixed by caulking, for example. The electrode 375 is connected to a wire 385 extending from an output terminal (different from the output terminal to which the electrode 370 is connected) disposed in the operation unit.
[0113]
The wire 385 includes a conductor 386 having a terminal connected to the electrode 375 and an electrical insulator 387 covering the conductor 386. The conducting wire 386 is fixed to the outer periphery of the sheath portion by, for example, adhesion.
[0114]
Next, a method for using the catheter according to Embodiment 3 will be described.
[0115]
First, the catheter is inserted into the living body, advanced to the vicinity of the target tissue, and the distal end portion 357 of the sheath portion is moved while measuring the action potential of the heart. Since the waveform pattern of the action potential of the heart measured by the electrode 375 is greatly different, contact between the distal end portion 357 of the sheath portion and the target tissue is recognized. 363 is protruded from the tip 357 of the sheath.
[0116]
At this time, if a large change occurs in the waveform pattern of the cardiac action potential measured by the electrode 375, it is determined that the distal end portion 357 of the sheath portion is separated from the target tissue due to the reaction of the protruding operation of the injection needle 363. Therefore, it is confirmed that the waveform pattern of the action potential of the heart measured by the electrode 375 does not change greatly during the protruding operation of the injection needle 363.
[0117]
On the other hand, when the injection needle 363 punctures the myocardial tissue and the electrode 370 moves into the myocardial tissue, a large change occurs in the waveform pattern of the cardiac action potential measured by the electrode 370. Therefore, puncture by the injection needle can be detected.
[0118]
In addition, even when the therapeutic composition is injected into the target tissue via the injection needle 363, it is confirmed that there is no significant change in the waveform pattern of the heart action potential measured by the electrode 370 and the electrode 375. To do. Thereby, it is possible to detect that the distal end portion 357 of the sheath portion is not separated from the target tissue and the injection needle 363 is not detached from the target tissue due to the reaction of the injection operation of the therapeutic composition.
[0119]
As described above, in the catheter according to Embodiment 3, the certainty regarding the puncture with the injection needle to the target tissue and the injection of the therapeutic composition is improved.
[0120]
Next, a catheter system according to Embodiment 4 will be described with reference to FIG. The fourth embodiment is generally different from the third embodiment in that a plurality of electrodes 470 and 471 that function as puncture sensors are disposed at the distal end portion 462 of the insertion member 460.
[0121]
The electrode 470 is disposed adjacent to the bevel of the injection needle 463, and the electrode 471 is disposed away from the electrode 470 in the longitudinal direction of the insertion member 460. The electrode 475 disposed at the distal end portion 457 of the sheath portion 455 is disposed on the proximal end side separated from the end face of the distal end portion 457.
[0122]
In addition, the catheter system according to Embodiment 4 includes a plurality of biological amplifiers 490A and 490B according to the configuration of the electrodes 470, 471, and 475 disposed at the distal end of the catheter. The biological amplifier 490A has an input terminal 491A (for example, for positive electrode) connected to the electrode 470 and an input terminal 493A (for example, for negative electrode) connected to the electrode 475. The biological amplifier 490B has an input terminal 491B (for example, for positive electrode) connected to the electrode 471 and an input terminal 493B (for example, for negative electrode) connected to the electrode 475. That is, the electrode 475 is connected to both the biological amplifiers 490A and 490B.
[0123]
In such a configuration, when the injection needle 463 punctures the target tissue and the electrode 470 contacts or moves inside the target tissue, a large change occurs in the waveform pattern of the cardiac action potential measured by the biological amplifier 490A. . Therefore, puncture by the injection needle 463 can be detected.
[0124]
Further, when the puncture depth of the injection needle 463 increases and the electrode 471 contacts or moves inside the target tissue, a large change occurs in the waveform pattern of the cardiac action potential measured by the biological amplifier 490B. Therefore, since the depth of the injection needle 463 can be detected, the injection needle 463 can be punctured more reliably.
[0125]
Next, a catheter system according to Embodiment 5 will be described with reference to FIG. In the fifth embodiment, a plurality of electrodes 570 and 571 are disposed at the distal end portion 562 of the insertion member 560, and a plurality of electrodes 575 and 576 are disposed at the distal end portion 557 of the sheath portion 555. Generally different from Form 3.
[0126]
The electrode 570 is disposed adjacent to the bevel of the injection needle 563, and the electrode 571 is disposed away from the electrode 570 in the longitudinal direction of the insertion member 560. The electrode 575 is disposed on the end surface of the distal end portion 557 of the sheath portion 555, and the electrode 576 is disposed on the proximal end side separated from the end surface of the distal end portion 557.
[0127]
The catheter system according to Embodiment 5 includes a plurality of biological amplifiers 590A and 590B according to the configuration of the electrodes 570, 571, 575, and 576 arranged at the distal end portion of the catheter. The biological amplifier 590A includes an input terminal 591A (for example, for positive electrode) connected to the electrode 570 and an input terminal 593A (for example, for negative electrode) connected to the electrode 571. The biological amplifier 590B has an input terminal 591B (for example, for positive electrode) connected to the electrode 575 and an input terminal 593B (for example, for negative electrode) connected to the electrode 576.
[0128]
In such a configuration, if the distal end portion 557 of the sheath portion 555 contacts the target tissue, a large change occurs in the waveform pattern of the cardiac action potential measured by the biological amplifier 590B. When the injection needle 563 punctures the target tissue and the electrode 570 contacts or moves inside the target tissue, a large change occurs in the waveform pattern of the cardiac action potential measured by the biological amplifier 590A. Therefore, puncture by the injection needle 563 can be detected.
[0129]
Further, when a large change occurs in the waveform pattern of the cardiac action potential measured by the biological amplifier 590B at the time of puncturing with the injection needle 563, the distal end portion 557 of the sheath portion 555 is targeted by the reaction of the protruding operation of the injection needle 563. It can be detected that it is away from the tissue. Similarly, when a therapeutic composition is injected, if a large change occurs in the waveform pattern of the cardiac action potential measured by the biological amplifier 590B, the distal end of the sheath 555 is caused by a reaction of the injection of the therapeutic composition. It can be detected that the part 557 is separated from the target tissue.
[0130]
As described above, in the fifth embodiment, the certainty regarding the puncture of the target tissue with the injection needle and the injection of the therapeutic composition is improved.
[0131]
Next, a modification of the catheter system according to Embodiment 5 will be described with reference to FIG. The modification is different in the arrangement position of the electrode 575 at the distal end portion 557 of the sheath portion 555 and the connection method between the electrodes 571 and 575 and the biological amplifiers 590A and 590B.
[0132]
That is, the electrode 575 is disposed at a position separated from the end surface of the distal end portion 557 of the sheath portion 555. The electrode 571 is connected to the input terminal 591B of the biological amplifier 590B. The electrode 575 is connected to the input terminal 593A of the biological amplifier 590A.
[0133]
In such a configuration, when the injection needle 563 punctures the target tissue and the electrode 570 contacts or moves in the target tissue, a large change occurs in the waveform pattern of the cardiac action potential measured by the biological amplifier 590A. . Therefore, puncture by the injection needle 563 can be detected.
[0134]
Further, when the puncture depth of the injection needle 563 becomes deep and the electrode 571 contacts or moves inside the target tissue, a large change occurs in the waveform pattern of the cardiac action potential measured by the biological amplifier 590B. Therefore, since the depth of the injection needle 563 can be detected, the puncture of the injection needle 563 can be made more reliable.
[0135]
Including the electrode 275 shown in FIG. 13 and the electrode 475 shown in FIG. 16, like the electrode 576 shown in FIG. 17 and FIG. As shown in FIG. 19, the sheath 555 can be embedded in the distal end portion 557. For example, after forming a concave portion along the circumferential direction in the distal end portion 557 of the sheath portion 555 and attaching the electrode to the concave portion by caulking and connecting the lead wire extending to the proximal end portion to the electrode It can be formed by covering the surface of the conducting wire with an electrical insulator.
[0136]
Furthermore, as shown in FIG. 20, the electrode can be disposed and fixed in the lumen of the sheath portion 555. For example, an electrode having an outer diameter slightly smaller than the inner diameter of the lumen of the sheath portion 555 is inserted into the lumen of the sheath portion 555, and from the end surface of the distal end portion 557 of the sheath portion 555 in the longitudinal direction of the sheath portion 555. It can be formed by bonding and fixing the electrode at a position advanced several mm.
[0137]
When the electrode is embedded or disposed and fixed in the lumen, it is preferable in that it can suppress, for example, the electrode from erroneously contacting the irregularities on the surface of the ventricle and causing a measurement error.
[0138]
Next, an example of the manufacturing method of the sheath part in which an electrode is arrange | positioned and an insertion member is demonstrated with reference to FIGS.
[0139]
As the sheath portion 655, a polyimide tube containing a blade wire containing tungsten carbide that functions as an X-ray contrast marker (manufactured by Micro-Lumen Corporation) was used. The polyimide tube has a three-layer structure in which blade wires are sandwiched, and has a length of 1300 mm, an outer diameter of 1.0 mm, and an inner diameter of 0.9 mm.
[0140]
One end (tip portion) of the polyimide tube was subjected to laser processing, and the blade line was exposed by peeling only the outermost polyimide layer of about 2 mm.
[0141]
And as FIG. 21 showed, the front-end | tip cap 657 was attached to the front-end | tip part of a polyimide tube. The tip cap 657 has a truncated cone shape made of SUS304, and an inner surface and an outer surface are covered with an electrical insulator.
[0142]
The outer diameter of the tip of the tip cap is 1.8 mm, the outer diameter of the attachment portion with the polyimide tube is 1.2 mm, and the length is 3 mm. The electrode 675 for measuring the heart action potential is constituted by an annular portion located inside the electrical insulator 687.
[0143]
The other end (base end portion) of the polyimide tube was also subjected to laser processing, and the blade line was exposed by peeling off only the outermost polyimide layer. Then, as shown in FIG. 23, a connection connector 686 was attached to the exposed portion of the blade line of the other end 656 of the polyimide tube.
[0144]
A wire 685 extending from an output terminal 651 disposed in the operation unit is connected to the connection connector 686. Note that the blade wire is connected to the conducting wire of the wire 685 inside the connection connector 681. The wire 685 extends a through hole formed in the drive unit 632.
[0145]
The insertion member 660 was formed by applying a polyimide varnish (electrical insulator) to the inner and outer surfaces using a hollow steel pipe (manufactured by Oba Kiko). The hollow steel pipe is made of SUS304 and has a length of 1500 mm, an outer diameter of 0.7 mm, and an inner diameter of 0.5 mm.
[0146]
The tip 662 of the insertion member 660 was polished to form a bevel 670 constituting the blade surface, as shown in FIG. The electrode for measuring the action potential of the heart is constituted by an annular part (annular part located between the electrical insulator 664 and the electrical insulator 682) from which the insulating film made of polyimide is peeled off.
[0147]
In the base end portion 661 of the insertion member 660, the blade line was exposed by peeling off only the outermost polyimide layer at an appropriate portion beyond the driving portion 632. Then, as shown in FIG. 23, the connection connector 681 was attached to the portion where the blade line was exposed. The connection connector 681 is connected to a wire 680 extending from an output terminal 650 disposed in the operation unit. Note that the blade wire is connected to the wire of the wire 680 inside the connection connector 681.
[0148]
By doing so, the electrodes for measuring the action potential of the heart could be arranged at the distal end portion of the insertion member and the distal end portion of the sheath portion.
[0149]
Next, referring to FIGS. 24 to 26, the results of animal experiments for verifying the detection of puncture by measuring the action potential of the heart will be described.
[0150]
The injection needle 763 used for puncturing was formed as follows. First, the side hole 765 was formed in the stainless steel hollow needle. The outer diameter of the hollow needle is 0.6 mm, and the inner diameter is 0.3 mm. The position of the side hole 765 is 10 mm away from the tip of the bevel of the hollow needle in the longitudinal direction of the hollow needle.
[0151]
Then, the conducting wire 781 was introduced from the side hole 765 into the lumen of the hollow needle and pulled out from the proximal end portion of the hollow needle. The diameter of the conducting wire 781 is 0.08 mm. In this state, the lead wire 781 was fixed to the lumen of the hollow needle by potting polyurethane resin into the lumen of the hollow needle.
[0152]
Thereafter, the lead 781 and the polyurethane resin protruding from the side hole 765 of the hollow needle were cut. Then, a file was applied so that the outer peripheral surface near the side hole 765 of the hollow needle and the cut surface became smooth. As a result, an electrode 770 made of a cut surface of the conductive wire 781 and an electrical insulator 764 made of polyurethane resin surrounding the electrode 770 and the conductive wire 781 were formed. Thus, the injection needle 763 applicable to animal experiments was obtained.
[0153]
Next, the contents of the animal experiment will be described.
[0154]
First, the subject pig was anesthetized by intramuscular injection of atropine, azaperone, and ketamine and inhalation of flucene. The heart was exposed by performing thoracotomy in a state where the trachea was incised and then delivered, and breathing was maintained by a ventilator.
[0155]
The lead wire 781 extending from the injection needle 763 is connected to the negative electrode input terminal of the biological amplifier, and the separate electrode to be brought into contact with the body surface is connected to the positive electrode input terminal of the biological amplifier, thereby the activity of the heart. It was set so that the potential could be measured. The biological amplifier is a Nihon Kohden poly amplifier.
[0156]
Thereafter, in order to confirm the thickness of the heart wall, the test needle was pierced from the outside of the heart into the heart tissue and gradually deeper. When the tip of the test needle reached the ventricle and blood flowed out from the proximal end of the test needle, the position was marked. Then, the approximate thickness of the heart wall was confirmed by removing the test needle and measuring the length from the tip of the test needle to the mark position.
[0157]
Next, by piercing the injection needle 763 in the vicinity of the puncture mark formed by the test needle, the waveform pattern of the cardiac action potential when the electrode 770 is present in the heart tissue was recorded. Then, by piercing the injection needle 763 further deeply, the waveform pattern of the cardiac action potential when the electrode 770 is located at the boundary between the tissue and blood was recorded.
[0158]
Thereafter, by piercing the injection needle 763 further deeply, the waveform pattern of the action potential of the heart when the electrode 770 was present in the blood in the ventricle was recorded.
[0159]
The waveform pattern of the heart action potential varied greatly between the case where the electrode 770 was present in blood (see FIG. 25) and the case where the electrode 770 was present in heart tissue (see FIG. 26). Note that there was no substantial change in the waveform pattern between the case where the electrode 770 is located at the boundary between the tissue and blood and the case where the electrode 770 is present in the heart tissue.
[0160]
As described above, it has been confirmed that there is a difference in the waveform pattern of the cardiac action potential between when the electrode is present in blood and when the electrode is in contact with or in the tissue. That is, it was verified that the puncture by the injection needle can be detected by the electrode arranged at the distal end portion of the catheter.
[0161]
Such a catheter 10 is applied to gene therapy and cell therapy, for example.
[0162]
Gene therapy is, for example, treatment for ischemic heart disease, and it is minimally invasive to inject a gene therapy composition (for example, a composition containing a nucleic acid) with an injection needle incorporated in a catheter. Is preferable.
[0163]
Cell therapy is a treatment method for improving cardiac function by transplanting new cells (cardiomyocytes, skeletal myoblasts, smooth muscle cells, bone marrow-derived cells, peripheral blood stem cells, cord blood-derived cells) from the outside, for example. It is. Therefore, the injection needle incorporated in the catheter can be applied, for example, for transplanting bone marrow-derived cells at and around the infarct site.
[0164]
In addition, the action potential of heart tissue differs between a healthy state and a state where the heart tissue is dead or dysfunctional. Therefore, by measuring the action potential, an abnormal part of the heart tissue, for example, an infarcted part can be specified. That is, it is possible to identify an abnormal part of the heart tissue by using the electrode arranged at the distal end portion of the catheter. Therefore, a high therapeutic effect is expected by injecting the therapeutic composition into the specified abnormal site and its surroundings.
[0165]
In addition, the present invention is not limited to being applied to the treatment of the heart, and can also be applied to the treatment of neovascularization of the lower limbs, for example.
[0166]
The present invention is not limited to the above-described embodiments, and various modifications can be made within the scope of the claims.
[0167]
【The invention's effect】
  According to the present invention described above, it is possible to provide a catheter and a catheter system that can reliably achieve puncture with a needle and injection of a therapeutic composition into a target tissue with minimal invasiveness..
[Brief description of the drawings]
FIG. 1 is a schematic view of a catheter according to Embodiment 1. FIG.
FIG. 2 is a cross-sectional view for explaining an operation unit shown in FIG.
FIG. 3 is a cross-sectional view for explaining the distal end portion of the catheter shown in FIG. 1, showing a state in which the injection needle protrudes.
4 is a cross-sectional view for explaining the distal end portion of the catheter shown in FIG. 1, showing a state in which the injection needle is retracted. FIG.
5 is a side view of the distal end portion of the insertion member of the catheter shown in FIG. 1. FIG.
FIG. 6 is a schematic view for explaining a catheter system to which the catheter shown in FIG. 1 is applied.
7 is a cross-sectional view of the distal end portion of the sheath portion for explaining a modified example of the catheter according to Embodiment 1. FIG.
8 is a side view of the distal end portion of the sheath portion shown in FIG.
9 is a schematic view of a catheter according to Embodiment 2. FIG.
10 is a cross-sectional view of the proximal end portion of the catheter shown in FIG. 9. FIG.
11 is a side view for explaining the distal end portion of the insertion member of the catheter shown in FIG. 9. FIG.
FIG. 12 is a schematic view for explaining a catheter system to which the catheter shown in FIG. 9 is applied.
FIG. 13 is a side view of the distal end portion of the sheath portion for explaining a modification of the catheter according to the second embodiment.
FIG. 14 is a schematic view for explaining a modification of the catheter system to which the catheter shown in FIG. 9 is applied.
FIG. 15 is a cross-sectional view for explaining the catheter according to the third embodiment.
FIG. 16 is a schematic diagram for explaining a catheter system according to a fourth embodiment.
FIG. 17 is a schematic diagram for explaining a catheter system according to a fifth embodiment.
FIG. 18 is a schematic diagram for explaining a modification of the catheter system according to the fifth embodiment.
19 is a side view of the distal end portion of the sheath portion for explaining another modified example of the catheter according to FIGS. 13, 16, 17 and 18. FIG.
FIG. 20 is a cross-sectional view of the distal end portion of the sheath portion for explaining a modified example different from FIG.
FIG. 21 is a side view for explaining an example of the manufacturing method of the sheath portion on which the electrode is arranged.
FIG. 22 is a side view for explaining an example of the manufacturing method of the insertion member in which the electrode is arranged.
23 is a schematic view for explaining the structure of the base end portion of the sheath portion shown in FIG. 21 and the base end portion of the insertion member shown in FIG.
FIG. 24 is a cross-sectional view for explaining an injection needle applied in an animal experiment for verifying detection of puncture by measurement of cardiac action potential.
FIG. 25 is a waveform diagram for explaining a verification result of an animal experiment, and shows a case where an electrode of an injection needle is present in blood.
FIG. 26 is a waveform diagram for explaining the verification result of the animal experiment, and shows a case where the electrode of the injection needle is present in the heart tissue.
[Explanation of symbols]
10 ... catheter system,
20 ... catheter,
21 ... proximal end,
22 ... the tip,
30 ... operation unit,
31 ... Housing,
32 ... Drive unit,
33 ... Slit,
34 ... O-ring,
35 ... stopper,
40 ... Needle control unit,
45 ... Hub,
50: Output terminal,
55 ... sheath,
56 ... proximal end,
57 ... the tip,
58 ... through hole,
60 ... insertion member,
61 ... proximal end,
62 ... the tip,
63 ... needle,
63A ... Bevel,
64. Electrical insulator,
70, 75 ... electrodes,
80 ... Wire,
81 ... conducting wire,
82 ... electric insulator,
85 ... Wire,
86 ... Lead wire,
87: Electrical insulator,
90 ... living body amplifier,
91: Input terminal,
92 ... code,
95: Input terminal,
96 ... code,
97 ... electrodes,
110 ... catheter system,
120 ... catheter,
121 ... proximal end,
122 ... the tip,
130 ... operation unit,
131 ... Housing,
132 ... drive unit,
133 ... slit,
134 ... O-ring,
135 ... stopper,
140 ... needle control unit,
145 ... Hub,
150, 151 ... output terminals,
155 ... sheath,
156 ... proximal end,
157 ... the tip,
160 ... insertion member,
161: proximal end,
162 ... the tip,
163 ... needle,
170, 175 ... electrodes,
180 ... wire,
181 ... lead wire,
182 ... an electrical insulator,
185 ... wire,
186 ... Lead wire,
187 ... electrical insulator,
190 ... living body amplifier,
191: Input terminal,
192 ... code,
193: Input terminal,
194 ... code,
195 ... Input terminal,
196 ... code,
197 ... electrodes,
210 ... catheter system,
270 ... electrodes,
281 ... Lead wire,
282 ... an electrical insulator,
275 ... electrodes,
286 ... Lead wire,
287 ... an electrical insulator,
290: biological amplifier,
291 ... Input terminal,
292 ... code,
295 ... Input terminal,
296 ... code,
297 ... electrodes,
357 ... the tip,
362 ... the tip,
363 ... needle,
363A ... Bevel,
364 ... an electrical insulator,
370, 375 ... electrodes,
380 ... wire,
381 ... Lead wire,
382 ... an electrical insulator,
385 ... Wire,
386 ... Lead wire,
387 ... electrical insulator,
455 ... sheath,
457 ... tip,
460 ... insertion member,
462 ... the tip,
463 ... needle,
470, 471, 475 ... electrodes,
490A, 490B ... biological amplifier,
491A, 493A, 491B, 493B ... input terminals,
555 ... sheath,
557 ... the tip,
560 ... insertion member,
562 ... the tip,
570, 571, 575, 576 ... electrodes,
590A, 590B ... biological amplifier,
591A, 593A, 591B, 593B ... input terminals,
632 ... Drive unit,
650, 651 ... output terminal,
655 ... sheath,
656 ... proximal end,
657 ... tip cap,
660 ... insertion member,
661 ... proximal end,
662 ... the tip,
663 ... needle,
664 ... electrical insulator,
670, 675 ... electrodes,
680 ... wire,
681 ... Connector,
682 ... an electrical insulator,
685: wire,
686 ... Connector,
687 ... electrical insulator,
763 ... needle,
764 ... electrical insulator,
765 ... side holes,
770 ... electrodes,
781 ... Lead wire.

Claims (10)

  1. A catheter that is percutaneously inserted into a body lumen,
    A sheath having a lumen extending the interior;
    An insertion member that is slidably disposed on the lumen of the sheath portion and has a distal end portion that can protrude from the distal end portion of the sheath portion;
    An injection needle disposed at the distal end of the insertion member for injecting a therapeutic composition into a target tissue in a living body;
    An electrode disposed at the distal end of the catheter, for measuring the action potential of the heart,
    The electrode has an electrode fixed to the distal end portion of the insertion member,
    The electrode fixed to the distal end portion of the insertion member is located on the outer peripheral surface of the distal end portion of the insertion member, and is separated from the bevel of the injection needle at the distal end portion of the insertion member, and the distal end portion of the insertion member A catheter that is electrically insulated from the inner peripheral surface of the catheter.
  2.   The catheter according to claim 1, wherein the target tissue is heart tissue.
  3.   The catheter according to claim 1 or 2, wherein the therapeutic composition contains a nucleic acid, a protein, or a cell.
  4.   The catheter according to any one of claims 1 to 3, wherein a distal end portion of the sheath portion has a through hole communicating with the lumen.
  5.   The catheter according to claim 4, wherein the through hole is separated from the end surface of the distal end portion of the sheath portion by 1 mm or more in the longitudinal direction of the sheath portion.
  6.   The said electrode arrange | positioned at the front-end | tip part of the said catheter is plurality, The electrode arrange | positioned at the front-end | tip part of the said sheath part is included, The one of Claims 1-5 characterized by the above-mentioned. catheter.
  7.   The catheter according to any one of claims 1 to 6, wherein there are a plurality of the electrodes arranged at a distal end portion of the insertion member, and the electrodes are spaced apart with respect to a longitudinal direction of the insertion member. .
  8.   The electrode disposed at the distal end portion of the insertion member is located only on the outer peripheral surface of the distal end portion of the insertion member, and is 1 mm or more away from the distal end of the injection needle in the longitudinal direction of the insertion member. The catheter of any one of Claims 1-8 characterized by these.
  9. A sheath portion having a lumen extending inside; an insertion member having a distal end portion slidably disposed on the lumen of the sheath portion and projectable from the distal end portion of the sheath portion; and a distal end portion of the insertion member A catheter that is disposed and has a syringe needle for injecting a therapeutic composition into a target tissue in a living body, and is inserted percutaneously into the living body lumen;
    A first electrode disposed at the distal end of the catheter for measuring a cardiac action potential;
    A second electrode for measuring the cardiac action potential;
    A conductor extending from the first electrode and a conductor extending from the second electrode are connected, and based on a heart action potential measured by the first electrode and the second electrode, A puncture detection device for detecting puncture,
    The first electrode is fixed to the outer peripheral surface of the distal end portion of the insertion member, is separated from the bevel of the injection needle at the distal end portion of the insertion member, and is electrically connected to the inner peripheral surface of the distal end portion of the insertion member. Is electrically insulated,
    The second electrode is disposed on the outer peripheral surface of the distal end portion of the insertion member or the distal end portion of the sheath portion, and is located on the proximal end side of the catheter with respect to the first electrode. system.
  10. A sheath portion having a lumen extending inside; an insertion member having a distal end portion slidably disposed on the lumen of the sheath portion and projectable from the distal end portion of the sheath portion; and a distal end portion of the insertion member A catheter that is disposed and has a syringe needle for injecting a therapeutic composition into a target tissue in a living body, and is inserted percutaneously into the living body lumen;
    A first electrode disposed at the distal end of the catheter for measuring a cardiac action potential;
    A second electrode for measuring the cardiac action potential;
    A conductor extending from the first electrode and a conductor extending from the second electrode are connected, and based on a heart action potential measured by the first electrode and the second electrode, A puncture detection device for detecting puncture,
    The first electrode is fixed to the outer peripheral surface of the distal end portion of the insertion member, is separated from the bevel of the injection needle at the distal end portion of the insertion member, and is electrically connected to the inner peripheral surface of the distal end portion of the insertion member. Is electrically insulated,
    The catheter system, wherein the second electrode is formed as a separate body independent of the catheter.
JP2003090225A 2003-03-28 2003-03-28 Catheter with puncture sensor Active JP4698128B2 (en)

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JP2003090225A JP4698128B2 (en) 2003-03-28 2003-03-28 Catheter with puncture sensor
US10/808,312 US7896851B2 (en) 2003-03-28 2004-03-25 Catheter with puncture sensor
AT04007391T AT344683T (en) 2003-03-28 2004-03-26 Catheter with punking sensor
EP06121531A EP1754502B1 (en) 2003-03-28 2004-03-26 Catheter with puncture sensor
EP20040007391 EP1462142B1 (en) 2003-03-28 2004-03-26 Catheter with puncture sensor
AT06121531T AT407720T (en) 2003-03-28 2004-03-26 Catheter with punking sensor
DE602004003085T DE602004003085T2 (en) 2003-03-28 2004-03-26 Catheter with puncture sensor
DE200460016574 DE602004016574D1 (en) 2003-03-28 2004-03-26 Catheter with puncture sensor

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JP2004290582A JP2004290582A (en) 2004-10-21
JP2004290582A5 JP2004290582A5 (en) 2006-04-27
JP4698128B2 true JP4698128B2 (en) 2011-06-08

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US (1) US7896851B2 (en)
EP (2) EP1754502B1 (en)
JP (1) JP4698128B2 (en)
AT (2) AT344683T (en)
DE (2) DE602004016574D1 (en)

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JP2004290582A (en) 2004-10-21
AT407720T (en) 2008-09-15
US7896851B2 (en) 2011-03-01
DE602004003085T2 (en) 2007-06-06
EP1754502B1 (en) 2008-09-10
DE602004003085D1 (en) 2006-12-21
EP1462142B1 (en) 2006-11-08
EP1462142A1 (en) 2004-09-29
AT344683T (en) 2006-11-15
US20040249295A1 (en) 2004-12-09
DE602004016574D1 (en) 2008-10-23
EP1754502A1 (en) 2007-02-21

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